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NCT04474470 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate NT219 Alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced Solid Tumors and Head and Neck Cancer
A Phase 1 study of Head and Neck Cancer and Solid Tumor, Adult, sponsored by TyrNovo.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 10
- Study locations
NCT04474470 is a Phase 1 study of Head and Neck Cancer and Solid Tumor, Adult that has completed, run by TyrNovo. The registered enrollment target is 52 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (80% lower). The trial reports 10 study locations across 6 states.
The verdict
NCT04474470, a Phase 1 study of Head and Neck Cancer and Solid Tumor, Adult, has completed, sponsored by TyrNovo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.
Conditions Studied
Interventions
- DRUG NT219
- DRUG NT219 and ERBITUX® - Dose Escalation
- DRUG NT219 and ERBITUX® - Expansion
Study Locations (10)
California
- California Cancer Associates for Research and Excellence - Encinitas
- The Angeles Clinic and Research Institute - Los Angeles
- UCSD Moores Cancer Center - San Diego
Other
- Hadassah University Medical Center - Jerusalem
- Rabin Medical Center - Petah Tikva
- Sourasky Medical Center - Tel Aviv
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Illinois
- The University of Chicago and Biological Sciences - Chicago
Louisiana
- Ochsner Clinic Foundation - New Orleans
Oklahoma
- Stephenson Cancer Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-09-03 |
| Est. Completion | 2024-05-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04474470
The ClinicalTrials.gov registry entry for NCT04474470 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (80% lower). The listed sponsor is TyrNovo, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which NT219 is the first listed.
NCT04474470 reports 10 study locations spanning 6 distinct geographic areas - top geographies include California, Other, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04474470 about?
NCT04474470 is a clinical study titled "A Study to Evaluate NT219 Alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced Solid Tumors and Head and Neck Cancer". This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or ...
What is the current status of trial NCT04474470?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2020-09-03. Estimated completion is 2024-05-08.
What conditions does trial NCT04474470 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Solid Tumor, Adult, Metastatic Solid Tumor, Squamous Cell Carcinoma of Head and Neck, Colorectal Adenocarcinoma.
What interventions are being tested in trial NCT04474470?
The interventions under investigation include: NT219 (DRUG), NT219 and ERBITUX® - Dose Escalation (DRUG), NT219 and ERBITUX® - Expansion (DRUG).
Who is sponsoring clinical trial NCT04474470?
This trial is sponsored by TyrNovo, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04474470 being conducted?
This trial has 10 study locations across California, District of Columbia, Illinois, Louisiana, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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